A clinical trial to test if RLY5016 is safe and can lower high blood potassium levels in patients with high blood pressure and kidney disease due to diabetes who are also taking standard medications for their disease.

• Conditions: Hyperkalemia in Patients with Hypertension and Diabetic Nephropathy; MedDRA version: 13.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 13.1Level: LLTClassification code 10020647Term: HyperkalemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 13.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000165-12-HU
• Lead Sponsor: Relypsa, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-29
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients must meet ALL of the following inclusion criteria:
1. Age 30 – 80 years old at screening
2. Type 2 diabetes mellitus (T2DM) diagnosed after age 30 which has been treated with oral medications or
insulin for at least one year prior to screening
3. Chronic kidney disease (estimated GFR 15 – < 60 mL/min/1.73m2 at screening based on central laboratory serum creatinine measurement)
4. Urine ACR = 100 mg/g at screening (S1) AND average urine ACR = 100 mg/g at the beginning of run-in
period (R0) based on up to 3 ACR values obtained starting at S1 and ending at the R0 Visit
5. Local laboratory serum K+ value of 4.5 – 5.0 mEq/L at screening (S1) AND local laboratory serum K+ value > 5.0 – < 6.0 mEq/L at randomization to RLY5016 (Baseline, T0 Visit)
6. Must be receiving an ACEI and/or ARB for at least 28 days prior to screening
7. Average systolic blood pressure = 140 – < 180 mmHg OR average diastolic blood pressure = 90 – < 110 mmHg (sitting) at screening
8. Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at
screening, and must have used a highly effective form of contraception for at least 3 months before RLY5016 administration, during the study, and for one month after study completion
9. Provide their written informed consent prior to participation in the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Patients must NOT meet ANY of the following exclusion criteria:
1. Type 1 diabetes mellitus
2. Hemoglobin A1c > 12% at screening or emergency treatment for T2DM within the last 3 months
3. Diabetic gastroparesis
4. Non-diabetic chronic kidney disease
5. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., cholectomy)
6. Current diagnosis of NYHA Class III or IV heart failure
7. Body mass index (BMI) = 40 kg/m2
8. Any of the following events having occurred within 2 months prior to screening: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, cardiac arrest or clinically significant ventricular arrhythmias, transient ischemic attack or stroke, use of any intravenous cardiac medication
9. Prior kidney transplant, or anticipated need for transplant during study participation
10. Active cancer, currently on cancer treatment or history of cancer in the past two years except for nonmelanocytic skin cancer which is considered cured
11. History of alcoholism or drug/chemical abuse within 1 year
12. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal
13. Loop and thiazide diuretics or other antihypertensive medications (calcium channel blocker, beta-blocker, alpha-blocker, or centrally acting agent) that have not been stable for at least 28 days prior to screening or not anticipated to remain stable during study participation
14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol, cholestyramine), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation
15. Current use of lithium
16. Use of potassium sparing medications, including aldosterone antagonists (e.g., spironolactone), potassium supplements, bicarbonate or baking soda in the last 7 days prior to screening
17. Use of any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening
18. Patients who have taken RLY5016 previously
19. Inability to consume the investigational product, or, in the opinion of the Investigator, inability to comply with the protocol
20. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardize the safety of the patient or affect the validity of the trial results

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified